809 results · 35ms · Sources: EU EUDAMED, US FDA

Gonococcal Antibody Tests

FDA Pre-Market Approval
FDA Class 3 ·FLUORESCENT GONORRHEA TEST-HEATED (FGT-H)

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval
FDA Class 3 ·Cerene Cryotherapy Device (Model Number FGS-7000)

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·Spatz3 Adjustable Balloon System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·Spatz3 Adjustable Balloon System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·Spatz3 Adjustable Balloon System

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval
FDA Class 3 ·Spatz3 Adjustable Balloon System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval
FDA Class 3 ·MISAGO RX Self-expanding Peripheral Stent

Wearable Automated External Defibrillator

FDA Pre-Market Approval
FDA Class 3 ·LifeVest Wearable Defibrillator

Ventilator, High Frequency

FDA Pre-Market Approval
FDA Class 3 ·MODEL 3100A HIGH FREQUENCY OCILLATORY VENTILATOR

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER DUCT OCCLUDER

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval
FDA Class 3 ·AMPLATZER SEPTAL OCCLUDER

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval
FDA Class 3 ·THE BELOS, TACHOS ATX, AND LEXOS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR FAMILIES AND CARDIAC AIRBAG

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval
FDA Class 3 ·WOLVERINE™ Coronary Cutting Balloon®

Glucose Oxidase, Glucose

FDA Pre-Market Approval
FDA Class 2 ·GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER

Glucose Oxidase, Glucose

FDA Pre-Market Approval
FDA Class 2 ·GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER

Glucose Oxidase, Glucose

FDA Pre-Market Approval
FDA Class 2 ·GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER

Glucose Oxidase, Glucose

FDA Pre-Market Approval
FDA Class 2 ·GLUCOWATCH(R) AUTOMATIC GLUCOSE BIOGRAPHER

Glucose Oxidase, Glucose

FDA Pre-Market Approval
FDA Class 2 ·GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER

Glucose Oxidase, Glucose

FDA Pre-Market Approval
FDA Class 2 ·GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER

Glucose Oxidase, Glucose

FDA Pre-Market Approval
FDA Class 2 ·GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER